WHO multinational study of three misoprostol regimens after mifepristone for early medical abortion. II: Side effects and women's perceptions

Helena Honkanen, Gilda Piaggio, Helena Von Hertzen, G. Bártfai, Radnaabazar Erdenetungalag, Kristina Gemzell-Danielsson, Sarala Gopalan, Mihai Horga, Fridtjof Jerve, Suneeta Mittal, Nguyen Thi Nhu Ngoc, Alexandre Peregoudov, R. N V Prasad, Alenka Pretnar-Darovec, Rashmi S. Shah, Si Song, Oi Shan Tang, Shang Chun Wu

Research output: Contribution to journalArticle

61 Citations (Scopus)

Abstract

Objectives: To compare the side effect profiles of regimens of oral and vaginal administration of misoprostol after a single oral dose of 200 mg of mifepristone and to investigate patients' perceptions of medical abortion. Design: Double-blind, randomised controlled trial. Setting: Fifteen gynaecological clinics in 11 countries. Population: A total of 2219 healthy pregnant women requesting medical abortion with ≤63 days of amenorrhoea. Two thousand women were asked about their perceptions of the method. Methods: Mifepristone 200 mg orally on day one, followed by 0.8 mg misoprostol either orally or vaginally on day three. The oral group (O/O group) and one of the vaginal groups (V/O group) continued with 0.4 mg of oral misoprostol, and the vaginal-only group (V-only group) with oral placebo, twice daily for seven days. Side effects were recorded daily by women and reported at each visit. After misoprostol administration at the clinic, side effects were recorded at 1-hour interval up to 3 hours. Patients' perceptions were asked at the second follow up visit, six weeks after treatment. Main outcome measures: The outcome measures were the following: pregnancy-related symptoms (nausea, vomiting, breast tenderness, fatigue, dizziness, headache), drug-related side effects (diarrhoea, fever, rash and blood pressure change), side effects related to the abortion process (lower abdominal pain) and women's perceptions of the method. Results: The pregnancy-related symptoms decreased in all groups after misoprostol, and breast tenderness decreased already after mifepristone. Oral administration of misoprostol was associated with a higher frequency of nausea and vomiting than vaginal administration at 1 hour after administration. With oral misoprostol, diarrhoea was more frequent at 1, 2 and at 3 hours after administration than with vaginal administration. Misoprostol induced fever during at least 3 hours after administration in up to 6% of the women, this peak being slightly higher and taking place later with the vaginal route. Lower abdominal pain peaked at 1 and 2 hours after oral misoprostol, while it did so at 2 and 3 hours after vaginal misoprostol. In the two groups that continued misoprostol, 27% of women had diarrhoea between the misoprostol visit and the two-week follow up visit, compared with 9% in the placebo group. Among the women studied, 84% would choose medical abortion again, 9% would choose surgical abortion and 7% did not know. Twenty-three percent of the women would choose to have a possible future abortion at home, 70% at a health facility and 7% did not know. Conclusions: The pregnancy-related symptoms decrease significantly with time during medical abortion. Nausea, vomiting and diarrhoea were more frequent after oral administration of misoprostol. Pain related to the abortion process occurs earlier after oral misoprostol. Should a need arise, a majority of women would choose medical abortion again and would prefer to have it at a health facility rather than at home.

Original languageEnglish
Pages (from-to)715-725
Number of pages11
JournalBJOG: An International Journal of Obstetrics and Gynaecology
Volume111
Issue number7
DOIs
Publication statusPublished - Jul 2004

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Misoprostol
Mifepristone
Intravaginal Administration
Diarrhea
Nausea
Vomiting
Oral Administration
Health Facilities
Pregnancy
Abdominal Pain
Breast
Fever
Placebos
Outcome Assessment (Health Care)
Pain Perception
Amenorrhea
Dizziness
Exanthema
Drug-Related Side Effects and Adverse Reactions
Fatigue

ASJC Scopus subject areas

  • Obstetrics and Gynaecology

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WHO multinational study of three misoprostol regimens after mifepristone for early medical abortion. II : Side effects and women's perceptions. / Honkanen, Helena; Piaggio, Gilda; Von Hertzen, Helena; Bártfai, G.; Erdenetungalag, Radnaabazar; Gemzell-Danielsson, Kristina; Gopalan, Sarala; Horga, Mihai; Jerve, Fridtjof; Mittal, Suneeta; Ngoc, Nguyen Thi Nhu; Peregoudov, Alexandre; Prasad, R. N V; Pretnar-Darovec, Alenka; Shah, Rashmi S.; Song, Si; Tang, Oi Shan; Wu, Shang Chun.

In: BJOG: An International Journal of Obstetrics and Gynaecology, Vol. 111, No. 7, 07.2004, p. 715-725.

Research output: Contribution to journalArticle

Honkanen, H, Piaggio, G, Von Hertzen, H, Bártfai, G, Erdenetungalag, R, Gemzell-Danielsson, K, Gopalan, S, Horga, M, Jerve, F, Mittal, S, Ngoc, NTN, Peregoudov, A, Prasad, RNV, Pretnar-Darovec, A, Shah, RS, Song, S, Tang, OS & Wu, SC 2004, 'WHO multinational study of three misoprostol regimens after mifepristone for early medical abortion. II: Side effects and women's perceptions', BJOG: An International Journal of Obstetrics and Gynaecology, vol. 111, no. 7, pp. 715-725. https://doi.org/10.1111/j.1471-0528.2004.00153.x
Honkanen, Helena ; Piaggio, Gilda ; Von Hertzen, Helena ; Bártfai, G. ; Erdenetungalag, Radnaabazar ; Gemzell-Danielsson, Kristina ; Gopalan, Sarala ; Horga, Mihai ; Jerve, Fridtjof ; Mittal, Suneeta ; Ngoc, Nguyen Thi Nhu ; Peregoudov, Alexandre ; Prasad, R. N V ; Pretnar-Darovec, Alenka ; Shah, Rashmi S. ; Song, Si ; Tang, Oi Shan ; Wu, Shang Chun. / WHO multinational study of three misoprostol regimens after mifepristone for early medical abortion. II : Side effects and women's perceptions. In: BJOG: An International Journal of Obstetrics and Gynaecology. 2004 ; Vol. 111, No. 7. pp. 715-725.
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title = "WHO multinational study of three misoprostol regimens after mifepristone for early medical abortion. II: Side effects and women's perceptions",
abstract = "Objectives: To compare the side effect profiles of regimens of oral and vaginal administration of misoprostol after a single oral dose of 200 mg of mifepristone and to investigate patients' perceptions of medical abortion. Design: Double-blind, randomised controlled trial. Setting: Fifteen gynaecological clinics in 11 countries. Population: A total of 2219 healthy pregnant women requesting medical abortion with ≤63 days of amenorrhoea. Two thousand women were asked about their perceptions of the method. Methods: Mifepristone 200 mg orally on day one, followed by 0.8 mg misoprostol either orally or vaginally on day three. The oral group (O/O group) and one of the vaginal groups (V/O group) continued with 0.4 mg of oral misoprostol, and the vaginal-only group (V-only group) with oral placebo, twice daily for seven days. Side effects were recorded daily by women and reported at each visit. After misoprostol administration at the clinic, side effects were recorded at 1-hour interval up to 3 hours. Patients' perceptions were asked at the second follow up visit, six weeks after treatment. Main outcome measures: The outcome measures were the following: pregnancy-related symptoms (nausea, vomiting, breast tenderness, fatigue, dizziness, headache), drug-related side effects (diarrhoea, fever, rash and blood pressure change), side effects related to the abortion process (lower abdominal pain) and women's perceptions of the method. Results: The pregnancy-related symptoms decreased in all groups after misoprostol, and breast tenderness decreased already after mifepristone. Oral administration of misoprostol was associated with a higher frequency of nausea and vomiting than vaginal administration at 1 hour after administration. With oral misoprostol, diarrhoea was more frequent at 1, 2 and at 3 hours after administration than with vaginal administration. Misoprostol induced fever during at least 3 hours after administration in up to 6{\%} of the women, this peak being slightly higher and taking place later with the vaginal route. Lower abdominal pain peaked at 1 and 2 hours after oral misoprostol, while it did so at 2 and 3 hours after vaginal misoprostol. In the two groups that continued misoprostol, 27{\%} of women had diarrhoea between the misoprostol visit and the two-week follow up visit, compared with 9{\%} in the placebo group. Among the women studied, 84{\%} would choose medical abortion again, 9{\%} would choose surgical abortion and 7{\%} did not know. Twenty-three percent of the women would choose to have a possible future abortion at home, 70{\%} at a health facility and 7{\%} did not know. Conclusions: The pregnancy-related symptoms decrease significantly with time during medical abortion. Nausea, vomiting and diarrhoea were more frequent after oral administration of misoprostol. Pain related to the abortion process occurs earlier after oral misoprostol. Should a need arise, a majority of women would choose medical abortion again and would prefer to have it at a health facility rather than at home.",
author = "Helena Honkanen and Gilda Piaggio and {Von Hertzen}, Helena and G. B{\'a}rtfai and Radnaabazar Erdenetungalag and Kristina Gemzell-Danielsson and Sarala Gopalan and Mihai Horga and Fridtjof Jerve and Suneeta Mittal and Ngoc, {Nguyen Thi Nhu} and Alexandre Peregoudov and Prasad, {R. N V} and Alenka Pretnar-Darovec and Shah, {Rashmi S.} and Si Song and Tang, {Oi Shan} and Wu, {Shang Chun}",
year = "2004",
month = "7",
doi = "10.1111/j.1471-0528.2004.00153.x",
language = "English",
volume = "111",
pages = "715--725",
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TY - JOUR

T1 - WHO multinational study of three misoprostol regimens after mifepristone for early medical abortion. II

T2 - Side effects and women's perceptions

AU - Honkanen, Helena

AU - Piaggio, Gilda

AU - Von Hertzen, Helena

AU - Bártfai, G.

AU - Erdenetungalag, Radnaabazar

AU - Gemzell-Danielsson, Kristina

AU - Gopalan, Sarala

AU - Horga, Mihai

AU - Jerve, Fridtjof

AU - Mittal, Suneeta

AU - Ngoc, Nguyen Thi Nhu

AU - Peregoudov, Alexandre

AU - Prasad, R. N V

AU - Pretnar-Darovec, Alenka

AU - Shah, Rashmi S.

AU - Song, Si

AU - Tang, Oi Shan

AU - Wu, Shang Chun

PY - 2004/7

Y1 - 2004/7

N2 - Objectives: To compare the side effect profiles of regimens of oral and vaginal administration of misoprostol after a single oral dose of 200 mg of mifepristone and to investigate patients' perceptions of medical abortion. Design: Double-blind, randomised controlled trial. Setting: Fifteen gynaecological clinics in 11 countries. Population: A total of 2219 healthy pregnant women requesting medical abortion with ≤63 days of amenorrhoea. Two thousand women were asked about their perceptions of the method. Methods: Mifepristone 200 mg orally on day one, followed by 0.8 mg misoprostol either orally or vaginally on day three. The oral group (O/O group) and one of the vaginal groups (V/O group) continued with 0.4 mg of oral misoprostol, and the vaginal-only group (V-only group) with oral placebo, twice daily for seven days. Side effects were recorded daily by women and reported at each visit. After misoprostol administration at the clinic, side effects were recorded at 1-hour interval up to 3 hours. Patients' perceptions were asked at the second follow up visit, six weeks after treatment. Main outcome measures: The outcome measures were the following: pregnancy-related symptoms (nausea, vomiting, breast tenderness, fatigue, dizziness, headache), drug-related side effects (diarrhoea, fever, rash and blood pressure change), side effects related to the abortion process (lower abdominal pain) and women's perceptions of the method. Results: The pregnancy-related symptoms decreased in all groups after misoprostol, and breast tenderness decreased already after mifepristone. Oral administration of misoprostol was associated with a higher frequency of nausea and vomiting than vaginal administration at 1 hour after administration. With oral misoprostol, diarrhoea was more frequent at 1, 2 and at 3 hours after administration than with vaginal administration. Misoprostol induced fever during at least 3 hours after administration in up to 6% of the women, this peak being slightly higher and taking place later with the vaginal route. Lower abdominal pain peaked at 1 and 2 hours after oral misoprostol, while it did so at 2 and 3 hours after vaginal misoprostol. In the two groups that continued misoprostol, 27% of women had diarrhoea between the misoprostol visit and the two-week follow up visit, compared with 9% in the placebo group. Among the women studied, 84% would choose medical abortion again, 9% would choose surgical abortion and 7% did not know. Twenty-three percent of the women would choose to have a possible future abortion at home, 70% at a health facility and 7% did not know. Conclusions: The pregnancy-related symptoms decrease significantly with time during medical abortion. Nausea, vomiting and diarrhoea were more frequent after oral administration of misoprostol. Pain related to the abortion process occurs earlier after oral misoprostol. Should a need arise, a majority of women would choose medical abortion again and would prefer to have it at a health facility rather than at home.

AB - Objectives: To compare the side effect profiles of regimens of oral and vaginal administration of misoprostol after a single oral dose of 200 mg of mifepristone and to investigate patients' perceptions of medical abortion. Design: Double-blind, randomised controlled trial. Setting: Fifteen gynaecological clinics in 11 countries. Population: A total of 2219 healthy pregnant women requesting medical abortion with ≤63 days of amenorrhoea. Two thousand women were asked about their perceptions of the method. Methods: Mifepristone 200 mg orally on day one, followed by 0.8 mg misoprostol either orally or vaginally on day three. The oral group (O/O group) and one of the vaginal groups (V/O group) continued with 0.4 mg of oral misoprostol, and the vaginal-only group (V-only group) with oral placebo, twice daily for seven days. Side effects were recorded daily by women and reported at each visit. After misoprostol administration at the clinic, side effects were recorded at 1-hour interval up to 3 hours. Patients' perceptions were asked at the second follow up visit, six weeks after treatment. Main outcome measures: The outcome measures were the following: pregnancy-related symptoms (nausea, vomiting, breast tenderness, fatigue, dizziness, headache), drug-related side effects (diarrhoea, fever, rash and blood pressure change), side effects related to the abortion process (lower abdominal pain) and women's perceptions of the method. Results: The pregnancy-related symptoms decreased in all groups after misoprostol, and breast tenderness decreased already after mifepristone. Oral administration of misoprostol was associated with a higher frequency of nausea and vomiting than vaginal administration at 1 hour after administration. With oral misoprostol, diarrhoea was more frequent at 1, 2 and at 3 hours after administration than with vaginal administration. Misoprostol induced fever during at least 3 hours after administration in up to 6% of the women, this peak being slightly higher and taking place later with the vaginal route. Lower abdominal pain peaked at 1 and 2 hours after oral misoprostol, while it did so at 2 and 3 hours after vaginal misoprostol. In the two groups that continued misoprostol, 27% of women had diarrhoea between the misoprostol visit and the two-week follow up visit, compared with 9% in the placebo group. Among the women studied, 84% would choose medical abortion again, 9% would choose surgical abortion and 7% did not know. Twenty-three percent of the women would choose to have a possible future abortion at home, 70% at a health facility and 7% did not know. Conclusions: The pregnancy-related symptoms decrease significantly with time during medical abortion. Nausea, vomiting and diarrhoea were more frequent after oral administration of misoprostol. Pain related to the abortion process occurs earlier after oral misoprostol. Should a need arise, a majority of women would choose medical abortion again and would prefer to have it at a health facility rather than at home.

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